This early phase I trial studies whether a Mayo-designed marker can easily be seen with ultrasound making it easier, faster, and more accurate for localization of positive axillary lymph nodes before surgery in patients with breast cancer. Mayo-designed twinkling marker may help improve the localization of positive lymph node in patients with breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04674852.
PRIMARY OBJECTIVE:
I. To show that the biologically inert, Food and Drug Administration (FDA)-approved material that comprises the Mayo-developed twinkling marker (Patent Application Title: Non-Metallic Ultrasound-Detectable Markers Patent Application No.: 62/903,078, Application Type: Provisional) is conspicuous under ultrasound.
SECONDARY OBJECTIVE:
I. To compare conspicuity of the twinkling marker with that of conventional biopsy markers and iodine I-125 (I-125) localization seeds.
OUTLINE:
Prior to surgery, patients undergo needle-guided placement of I-125 and the Mayo twinkling marker on day 0 followed by standard mammogram or ultrasound. Patients also undergo a preoperative axillary ultrasound on day 0 for localization. After localization, patients undergo surgical resection of the localized lymph nodes on day 1 per standard of care. At the time of surgery, patients undergo collection of a tissue sample for a specimen radiograph.
Trial PhaseNo phase specified
Trial Typedevice
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorChristine U. Lee
